Your session is about to expire
← Back to Search
ABX464 Maintenance Therapy for Ulcerative Colitis
Verified Trial
Phase 3
Recruiting
Led By Bruce Sands, MD, PhD
Research Sponsored by Abivax S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 44
Awards & highlights
Study Summary
This trial is to evaluate the long-term effects of ABX464 on ulcerative colitis sufferers who have not responded to other treatments.
Who is the study for?
This trial is for people with moderate to severe ulcerative colitis who didn't get better with standard or advanced treatments. They must have finished a previous ABX464 study and can't be planning pregnancy soon. Participants need valid endoscopy results, agree to use effective contraception, sign consent forms, and commit to the study schedule.Check my eligibility
What is being tested?
The trial tests long-term effects of two doses of ABX464 (50mg or 25mg) as daily maintenance therapy compared to a placebo. It's randomized: some get the real drug without knowing if it's high or low dose; others get a fake pill. The treatment lasts 44 weeks followed by an evaluation after another 28 days.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to ABX464 which could include typical drug-related issues like gastrointestinal discomfort, potential allergic reactions, or other organ-specific inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 44
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 44
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of subjects in clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1 (friability is scored as 2)] at Week 44
Secondary outcome measures
Proportion of subjects with HEMI per Geboes scoring at Week 44
Adrenal Cortex Hormones
Proportion of subjects with endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44
+3 moreSide effects data
From 2019 Phase 2 trial • 32 Patients • NCT0309325917%
Abdominal pain
17%
Headache
13%
Abdominal pain upper
9%
Chest pain
9%
Influenza like illness
9%
Nausea
4%
Oropharyngeal pain
4%
Haematoma
4%
Peripheral vascular disorder
4%
Dyspnoea
4%
Dyspepsia
4%
Alopecia
4%
Rhinitis
4%
Hypophosphataemia
4%
Anorectal discomfort
4%
Nasopharyngitis
4%
Oral herpes
4%
Anal fissure
4%
Influenza
4%
Sinusitis
4%
Upper respiratory tract infection
4%
Ligament sprain
4%
AST/ALT ratio
4%
Iron deficiency
4%
Back pain
4%
Poor quality sleep
4%
Skin discolouration
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABX464
Placebo
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: ABX464 50mg - Responder subjects at the end of inductionExperimental Treatment1 Intervention
Subjects will be orally dosed during 44 weeks
Group II: ABX464 50mg - Non responder subjects at the end of inductionExperimental Treatment1 Intervention
Subjects will be orally dosed during 44 weeks
Group III: ABX464 25mg - Responder subjects at the end of inductionExperimental Treatment1 Intervention
Subjects will be orally dosed during 44 weeks
Group IV: ABX464 25mg - Non responder subjects at the end of inductionExperimental Treatment1 Intervention
Subjects will be orally dosed during 44 weeks
Group V: Placebo - Responder subjects at the end of inductionPlacebo Group1 Intervention
Subjects will be orally dosed during 44 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABX464
2021
Completed Phase 2
~310
Find a Location
Who is running the clinical trial?
Abivax S.A.Lead Sponsor
20 Previous Clinical Trials
3,215 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
1,952 Patients Enrolled for Ulcerative Colitis
Bruce Sands, MD, PhDPrincipal InvestigatorMount Sinai Health System Digestive Disease Institute, New York USA
1 Previous Clinical Trials
612 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
612 Patients Enrolled for Ulcerative Colitis
Severine Vermeire, MD, PhDPrincipal InvestigatorUZ Leuven, Belgium
1 Previous Clinical Trials
612 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
612 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to try for a baby in the next year.I have had an endoscopy with results read by a central reader.I have read, understood, and signed the consent form for this study.I am using or willing to use effective birth control as required.
Research Study Groups:
This trial has the following groups:- Group 1: ABX464 50mg - Responder subjects at the end of induction
- Group 2: ABX464 25mg - Responder subjects at the end of induction
- Group 3: Placebo - Responder subjects at the end of induction
- Group 4: ABX464 50mg - Non responder subjects at the end of induction
- Group 5: ABX464 25mg - Non responder subjects at the end of induction
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has ABX464 50mg been proven to be a safe dosage for people who do not respond positively to induction?
"The level of safety associated with the drug ABX464 50mg - Non responder subjects at the end of induction is a 3, as it has undergone extensive clinical testing and efficacy data has been established."
Answered by AI
How many people are currently participating in this research venture?
"Affirmative. Data on clinicaltrials.gov shows that the trial is actively enrolling people, beginning from January 16th 2023 and last updated on the 31st of January. 1050 participants are being sought out at a single site."
Answered by AI
Are there any openings to join the research team at this time?
"Affirmative. Information found on clinicaltrials.gov affirms that this investigation is currently accepting participants, having first been posted on January 16th 2023 and revised as of the 31st of January in the same year. 1050 individuals are being sought from a single location to participate in this trial."
Answered by AI
Who else is applying?
What site did they apply to?
Digestive Health Specialists of the Southeast
MedOne Clinical Research LLC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger